Protocol Registration Forms

FDA required document in which clinical investigators agree to conduct the clinical trials according to U.S. Federal regulations. The Form FDA 1572 is signed by the investigator and a copy is submitted to the IND Sponsor.

A form required by DAIDS for non-IND studies that are sponsored and/or supported by DAIDS. By signing the document, the IoR affirms that he/she will conduct the clinical trial according to applicable U.S. Federal regulations, local laws, DAIDS requirements and DAIDS policies.

For all documents that require translation to a language other than Spanish, a CRS must submit to the DAIDS RSC PRO a copy of the DAIDS Protocol Registration Translation Confirmation Document, attesting that the translation is a true and accurate reflection of the local language documents that have been reviewed and approved by the IRB/EC and other REs/Approving Entities.